At Hitma, we understand that clear, standardized documentation is crucial for integrating single-use assemblies into your regulated process.
Therefore, we provide extensive documentation with all our single-use solutions. This information supports you in conducting risk assessments and complying with guidelines. We ensure complete traceability of components, integrity and compatibility tests, and support with your IQ/OQ/PQ documentation.
We are able to provide the following documentation with our single-use solutions, depending on your quality requirements:
- Validation guides
- Certificate of Conformity (CoC)
- Certificate of Analysis (CoA)
- Certificate of Sterilization (CoI)
- Additional testing such as: particles (USP788), bacterial endotoxin (USP788)
- Batch records and component lists
- IQ/OQ/PQ requirements
- Extractables/leachables test results
- Sterilization validation and certification
- Complete validation dossier